FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitori

Description

Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572.

In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly.

Why should you attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important.

Areas Covered in the Session:

* What doe the FDA look at when Auditing/Inspecting a study?
* The Sponsor's responsibility in monitoring study conduct
* Components of a sponsor monitoring system beyond SOPs
* The nature of adequate oversight of all staff and non-staff
* The importance of Protocol knowledge in preventing errors
* How do sites prepare for an audit / inspection
* The measures to ensure quality monitoring

Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: